GMP QC Analyst I/ II

Position: GMP QC Analyst I/ II

FLSA Status: Exempt

Salary Range: $65,000 - $70,000 / yr

Location: Exton, PA (ON-SITE)

Job Overview:

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We are seeking a highly motivated GMP QC Analyst I/ II to join our CellGene Therapy (CGT) Quality Control team. The QC Analyst I/ II will be responsible for executing routine laboratory testing under cGMP conditions to support multiple client projects in various phases of development. This role is suitable for candidates seeking to gain hands-on experience in a dynamic, client-focused, cross-functional CGT laboratory.

The ideal candidate will have a strong foundation in biological sciences and laboratory techniques, along with a commitment to quality and regulatory compliance.

Responsibilities:

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• Perform analytical testing of all samples in accordance with GMP regulations and internal SOPs.
  
• Execute a variety of biological assays including, but not limited to, ELISA, qPCR, ddPCR, and cell-based potency assays.
  
• Perform aseptic cell culture work, including the maintenance, expansion and passaging of mammalian cell lines.
  
• Support cell line banking activities, including preparation, cryopreservation and retrieval of cell stocks.
  
• Support method qualification, transfer and validation activities for client-specific methods.
  
• Prepare reagents, media, buffers, solutions, and test samples as per SOPs.
  
• Calibrate and maintain laboratory instruments; report any malfunctions or deviations.
  
• Perform laboratory cleaning and/or maintenance activities as assigned.
  
• Participate in laboratory investigations, deviations, CAPAs, Effectiveness Checks, KLEs and change controls.
  
• Assist in maintaining lab inventory and requesting of supplies/ forms.
  
• Maintain accurate and complete documentation in compliance with data integrity standards and ALCOA+ and GMP data integrity standards.
  
• Maintain a clean, safe, and compliant lab environment per company policies and regulatory guidelines.
  
• Collaborate cross-functionally with QA, CGT RD, and other departments.
  
• May assist with biennial SOP review, peer-review, drafting of protocols and reports or other documentation at management's discretion.
  

What We're Looking For:

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• Degree in a related field (e.g., Biology, Cell Biology, Biotechnology, Biochemistry, Chemistry, life sciences)
  
• QC Analyst I: Bachelor's degree with 1-3 years of experience or a Master's degree with 0-1 year of experience.
  
• QC Analyst II: Bachelor's degree with 2-5 years of experience or a
  

Master's degree with 1-3 years of experience.

• Working knowledge of aseptic technique, cell culture and basic molecular biology methods.
  
• Ability to evaluate technical data and record data accurately and legibly
  

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, DentalVision with significant employer contributions
  
• Employer-funded Health Reimbursement Account
  
• HealthcareDependent Care Flexible Spending Accounts
  
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
  
• 401k plan with generous employer match
  
• Access to an Employee Assistance Program
  

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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